A Study to Investigate Single Ascending Doses of Ocrelizumab for Safety and Side Effects, How The Body Handles It Over A Period of Time, How The Body Notices and Reacts To It, And Its Effect On The Body When Given As A Subcutaneous Injection In Patients With Multiple Sclerosis

End 18 Mar 2025 · Status Ended · 5 EU/EEA countries · 14 sites · Protocol WN45319

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other

Status Ended

Participants planned 75

Countries 5

Sites 14

Multiple Sclerosis (MS)

Key facts

Sponsor: F. Hoffmann-La Roche AG
Participant type: Patients
Age range: 18-64 years
Gender: Male and Female
Therapeutic area: Diseases [C] - Immune System Diseases [C20], Diseases [C] - Nervous System Diseases [C10]
Trial duration: completed 18 Mar 2025
Decision date (initial): 2024-10-18
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Multiple Sclerosis (MS)

Version	Level	Code	Term	System organ class
20.1	PT	10028245	Multiple sclerosis	100000004852

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

F. Hoffmann-La Roche AG

Sponsor organisation: F. Hoffmann-La Roche AG
Address: Grenzacherstrasse 124
City: Basel
Postcode: 4058
Country: Switzerland

Scientific contact point

Organisation: F. Hoffmann-La Roche AG
Contact name: Trial Information System - TISL

Public contact point

Organisation: F. Hoffmann-La Roche AG
Contact name: Trial Information System - TISL

Locations

5 EU/EEA countries · 14 investigational sites

By country

Country	MS status	Planned subjects	Sites
Belgium	Ended	6	2
Czechia	Ended	13	4
France	Ended	9	3
Poland	Ended	10	3
Spain	Ended	6	2
Rest of world Brazil, Mexico, United Kingdom, United States	—	31	—

Investigational sites

Belgium

2 sites · Ended

Antwerp University Hospital

Neurology, Drie Eikenstraat 655, 2650, Edegem

Universitair Ziekenhuis Gent

Neurology, Corneel Heymanslaan 10, 9000, Gent

Czechia

4 sites · Ended

Fakultni Nemocnice Hradec Kralove

Neurologická klinika, Sokolska 581, 500 03, Novy Hradec Kralove

Krajska zdravotni a.s.

MS centrum při neurologickém oddělení, Duchcovska 53, 415 01, Teplice

Nemocnice Jihlava prispevkova organizace

Neurologické oddělení, Vrchlickeho 4630/59, 586 01, Jihlava 1

Nemocnice Pardubickeho kraje a.s.

Neurologická klinika, Kyjevska 44 Pardubicky, 530 03, Pardubice

France

3 sites · Ended

Centre Hospitalier Universitaire De Nantes

Neurologie, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain

Assistance Publique Hopitaux De Paris

Neurologie, 43 Boulevard De L Hopital, 75013, Paris

Centre Hospitalier Universitaire De Montpellier

Neurologie, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5

Poland

3 sites · Ended

Neurocentrum Bydgoszcz Sp. z o.o.

NA, Ul. Aleje Prof. Sylwestra Kaliskiego 28/U1, 85-796, Bydgoszcz

ProNeuro Centrum Medyczne

NA, ul. Aleja Zjednoczonej Europy 37, 44-240, Zory

Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach

NA, Ul. 3 Maja 13/15, 41-800, Zabrze

Spain

2 sites · Ended

Hospital Universitario Quironsalud Madrid

Neurología, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon

Hospital Universitari Vall D Hebron

Neurología, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-06-24	Czechia	Acceptable with conditions 2024-10-14	2024-10-14